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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K253116

510(k) cleared

3D MAC Titanium Cranial Plate (TCP) System

The Surgeon General, Department of the Army (TSG-DA) · Jun 18, 2026 · K253116

FDA cleared the 3D MAC Titanium Cranial Plate (TCP) System from The Surgeon General, Department of the Army (TSG-DA) on Jun 18, 2026 under K253116, a traditional 510(k). The device falls under product code GXN, Plate, Cranioplasty, Preformed, Non-Alterable, regulated at 21 CFR 882.5330 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 24, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for The Surgeon General, Department of the Army (TSG-DA) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253116?

K253116 is the FDA 510(k) for 3D MAC Titanium Cranial Plate (TCP) System, submitted by The Surgeon General, Department of the Army (TSG-DA). FDA's decision date was Jun 18, 2026, under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable).

Who makes the 3D MAC Titanium Cranial Plate (TCP) System?

The Surgeon General, Department of the Army (TSG-DA), based in Fort Detrick, MD, is the applicant of record for K253116.

How long did the K253116 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Jun 18, 2026, 267 days later.

← All decisions in June 2026